China NMPA legacy archive 国械注准20243131544Patient-matched joint filler blocks
- Device class
- Class III
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243131544
- Approval date
- August 22, 2024
- Expiry date
- August 21, 2029
- Province/Region
- Tianjin
- Address
- No. 318, Jingyi Road, Tianjin Airport Economic Zone
- Production address
- 天津空港经济区经一路318号
The product is bio-fixed with bone or screw-and-bio-fixation, and with joint replacement prosthesis by bone cement, and is suitable for filling periarticular bone defects during revision and replacement of hip and knee joints.
该产品与骨通过生物固定或螺钉和生物固定、与关节置换假体通过骨水泥固定，适用于髋关节和膝关节的翻修置换术中关节周围骨缺损的填充。
The patient-matched joint filling block is made of Ti6Al4V titanium alloy powder material in accordance with ISO 5832-3 by additive manufacturing technology. The product is delivered in a non-sterile state.
患者匹配关节填充块由符合ISO 5832-3规定的Ti6Al4V钛合金粉末材料经增材制造技术制成。产品以非灭菌状态交付。
- Appendix
- 产品技术要求
This static archive preserves historical registration fields and translations for Patient-matched joint filler blocks, registration 国械注准20243131544. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.